Actively Recruiting

Phase Not Applicable
Age: 6Months - 7Months
All Genders
Healthy Volunteers
NCT07451951

Effectiveness of Small-Quantity vs Medium-Quantity Lipid-Based Nutrient Supplements for Prevention of Undernutrition in Children 6-12 Months

Led by Aga Khan University · Updated on 2026-05-04

980

Participants Needed

2

Research Sites

56 weeks

Total Duration

On this page

Sponsors

A

Aga Khan University

Lead Sponsor

U

United Nations World Food Programme (WFP)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Nutrition is essential for a child's growth, brain development, and protection from disease. While breastmilk provides the best nutrition for young infants, children older than six months may not get all the nutrients they need from breastmilk and regular foods alone. For this reason, some children receive special nutrient supplements to support healthy growth. Lipid-based nutrient supplements (LNS) are one type of supplement that provides important vitamins and minerals. These supplements are used in many countries to help prevent undernutrition in young children. In Pakistan, the government social safety net program currently provides medium-quantity LNS to children starting at six months of age. However, it is not known whether a smaller-quantity LNS could provide similar benefits for children in this age group from under-resourced communities that have limited access to nutritious foods. The goal of this trial is to learn whether small-quantity lipid-based nutrient supplements (SQ-LNS) work as well as medium-quantity lipid-based nutrient supplements (MQ-LNS) in preventing undernutrition in children aged six to twelve months. The main questions this study aims to answer are: * Does SQ-LNS work as well as MQ-LNS in supporting healthy growth, including reducing stunting, wasting, and underweight? * Does SQ-LNS work as well as MQ-LNS in reducing anemia? Researchers will compare SQ-LNS and MQ-LNS to see if SQ-LNS is as good as MQ-LNS in preventing undernutrition. Participants will: * Receive either SQ-LNS or MQ-LNS once daily for 6 months * Have their length, weight and mid-upper arm circumference (MUAC) measured monthly * Have their blood tested for anemia at the start and end of supplementation

CONDITIONS

Official Title

Effectiveness of Small-Quantity vs Medium-Quantity Lipid-Based Nutrient Supplements for Prevention of Undernutrition in Children 6-12 Months

Who Can Participate

Age: 6Months - 7Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 months to 6 months and 29 days with weight-for-length z-score (WLZ) ≥ -2 standard deviation (SD) and mid-upper arm circumference (MUAC) ≥125 mm, born to mothers who are beneficiaries of the Benazir Income Support Programme and registered with the Benazir Nashonuma Programme (BNP) at any point during their pregnancy.
  • Permanent residents of the selected districts, with no plan to relocate or migrate within the next 6 months.
  • Written informed consent provided by the child's caregivers.
Not Eligible

You will not qualify if you...

  • Children with moderate acute malnutrition (MAM), defined as WLZ ≥ -3 to < -2 SD, or MUAC ≥115 mm to <125 mm.
  • Children with severe acute malnutrition (SAM), defined as WLZ < -3 SD or MUAC <115 mm or presence of bilateral pitting edema, who require therapeutic feeding.
  • Children with known congenital anomalies, chronic illness, or conditions affecting growth or feeding (for example, cerebral palsy or congenital heart disease).
  • Children already enrolled in any nutritional supplementation other than BNP or another clinical trial.
  • Children whose families will be unwilling to provide informed consent, or likely to be unavailable for follow-up.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

BNP Facilitation Centers

Peshawar, Khyber Pakhtunkhwa, Pakistan

Not Yet Recruiting

2

BNP Facilitation Centers

Dadu, Sindh, Pakistan

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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